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- Ensayo clínico NCT01833988
The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas
10 de agosto de 2017 actualizado por: Steven J. Russell, MD, PhD, Massachusetts General Hospital
The Summer Camp Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population at the Clara Barton Diabetes Camps
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual care for young people with type 1 diabetes 12-20 in a diabetes camp environment.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The bionic pancreas will be compared to usual care in a crossover design in which each volunteer will serve as his or her own control.
Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a one day washout period in between.
Tipo de estudio
Intervencionista
Inscripción (Actual)
32
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 20 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age 12-20 years with type 1 diabetes for at least one year.
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least three months prior to enrollment.
- Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion).
Exclusion Criteria:
- Unable to provide informed assent
- Unable to comply with study procedures.
- Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
- Total daily dose (TDD) of insulin that is > 2 units/kg.
- Pregnancy (positive urine HCG), plan to become pregnant in the immediate future, or sexually active without use of contraception
- Hypoglycemia unawareness (self-reported or legal guardian report of consistent lack of hypoglycemia symptoms when BG is < 50 mg/dl)
- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
- History of prolonged QT or arrhythmia
- History of congenital heart disease or current known cardiac disease
- Acute illness (other than non-vomiting viral illness) or exacerbation of chronic illness other than type 1 diabetes at the time of the study.
- Seizure disorder or history of hypoglycemic seizures or coma in the last five years
- Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with second generation anti-psychotic medications, which are known to affect glucose regulation.
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radiofrequency interference.
- Use non-insulin, injectable (e.g. exenatide, pramlintide) or oral (e.g. thiazolidinediones, biguanides, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors, acarbose)anti-diabetic medications.
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
- Unwilling or unable to completely avoid acetaminophen during the usual care and closed-loop BG control portions of the study.
- History of eating disorder such as anorexia, bulimia, "diabulemia" or omission of insulin to manipulate weight
- History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
- Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Cuidado usual
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Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.
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Experimental: Bi-hormonal Bionic Pancreas
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Automated blood glucose control via a closed-loop bionic pancreas device.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours.
Periodo de tiempo: 1 week
|
1 week
|
Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm
Periodo de tiempo: 1 week
|
1 week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Average BG as Determined From All HemoCue Measurements Taken During the Day/Nighttime Including All Extra Measurements.
Periodo de tiempo: 1 week
|
Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in average BG as determined from all HemoCue measurements taken during the day/nighttime including all extra measurements taken before meals, taken during exercise, and taken for hypoglycemia monitoring.
|
1 week
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl
Periodo de tiempo: Day 2-5
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Day 2-5
|
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Difference in the Percentage of Study Days With Mean CGM BG </= 154 mg/dl Over the Duration of the Closed-loop Period vs. the Usual Care Period
Periodo de tiempo: Day 2-5
|
Day 2-5
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Hypoglycemic Events (BG <70mg/dl) as Determined From HemoCue Measurements
Periodo de tiempo: Day 1-5
|
Day 1-5
|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
Periodo de tiempo: 1 week
|
1 week
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise
Periodo de tiempo: 1 week
|
1 week
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise
Periodo de tiempo: 1 week
|
1 week
|
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Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm)
Periodo de tiempo: 1 week
|
1 week
|
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Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG)
Periodo de tiempo: Day 2-5
|
Day 2-5
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Day 2-5
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Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure)
Periodo de tiempo: 1 week
|
1 week
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure)
Periodo de tiempo: 1 week
|
1 week
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl
Periodo de tiempo: 1 week
|
1 week
|
|
Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals
Periodo de tiempo: 1 week
|
1 week
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise
Periodo de tiempo: 1 week
|
1 week
|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.
Periodo de tiempo: 1 week
|
Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in standard deviation of CGMG values (glycemic variability) in different BG ranges. %<70 70-120 70-180 %>180 %>250 |
1 week
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)
Periodo de tiempo: 1 week
|
1 week
|
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Difference Between Closed-loop and Open-loop in Average BG as Determined From All HemoCue Measurements Taken During the Nighttime Including All Extra Measurements Taken for Hypoglycemia Monitoring.
Periodo de tiempo: 1 week
|
1 week
|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Time Spent in Hypoglycemia (Plasma BG <Than 70 mg/dl) at Night
Periodo de tiempo: 1 week
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1 week
|
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Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
Periodo de tiempo: 1 week
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1 week
|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night
Periodo de tiempo: Day 2-5
|
Day 2-5
|
Day 2-5
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night
Periodo de tiempo: 1 week
|
1 week
|
|
Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) at Night
Periodo de tiempo: 1 week
|
1 week
|
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Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) at Night
Periodo de tiempo: 1 week
|
1 week
|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia
Periodo de tiempo: 1 week
|
1 week
|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night
Periodo de tiempo: 1 week
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1 week
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
---|---|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose
Periodo de tiempo: 1 week
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1 week
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2013
Finalización primaria (Actual)
1 de agosto de 2013
Finalización del estudio (Actual)
1 de diciembre de 2014
Fechas de registro del estudio
Enviado por primera vez
13 de abril de 2013
Primero enviado que cumplió con los criterios de control de calidad
13 de abril de 2013
Publicado por primera vez (Estimar)
17 de abril de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de septiembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
10 de agosto de 2017
Última verificación
1 de agosto de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2013p000561
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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